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Azathioprine Based on Endoscopy After Clinical Remission in Moderate to Severe Ulcerative Colitis — ACE  

Ulcerative Colitis Clinical Trial

Clinical Trial Summary

The aim of this study is to determine whether azathioprine is effective for mucosal healing in UC patients who achieved clinical remission by the first course of corticosteroids but not mucosal healing in endoscopy.

Clinical Trial Description

The sample size was calculated based on the previous study showing the difference of mucosal healing rate between azathioprine (58%) and 5-aminosalicylate (21%). With a two-tailed test of α = 0.05 and 1 - ß = 0.8, 52 patients were required.

The placebo drug which is identical to azathioprine will be provided by Celltrion drug company.

Differences in the categorical variables between the groups are examined with χ2 or the Fisher exact test. For comparisons of continuous variables, a Student t test is used. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02579733
Study type Interventional
Source Kyungpook National University
Contact
Status Terminated
Phase Phase 4
Start date February 1, 2016
Completion date December 1, 2018
View Details
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